Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
Position Summary:
The Principal Manufacturing Chemist will be responsible for overseeing and participating in the technical transfer and execution of GMP and non-GMP manufacturing of intermediate and drug substance API. This position is responsible for writing and reviewing batch records, reviewing SOPs and quality documents associated with manufacturing, and maintaining a safe working environment. This position is expected to delegate tasks to junior staff and perform other supervisory tasks and oversee day-to-day operations and personnel as directed by DSDM Manager or Director.
Responsibilities
Key Job Responsibilities:
Draft non-GMP and GMP batch records from process description using template, as needed. Review batch records written by other Manufacturing Chemists and review executed batch records.
Scale up and order materials for non-GMP and GMP manufacturing operations as needed.
Assess process fit and identify appropriate manufacturing equipment. Suggest operational changes as appropriate.
Identify and understand process safety hazards and applicable mitigation strategies. Collaborate with Process Chemistry Development and EHS to address safety risks identified during process review. Helps drive safety culture in Manufacturing group.
Complete lab-scale front runs using GMP materials as needed.
On the floor support and/or oversight of drug substance manufacturing operations in coordination with DSDM manager.
Support a Quality culture within the department by setting the right example, providing training as needed and maintain accountability throughout DSDM GMP operations.
Consistently, clearly, and accurately document activities for production records and manufacturing equipment in accordance with ALCOA, cGMP, and Good Documentation Practices (GDP).
Write change controls and deviation responses for minor, major, and critical deviation investigations.
Write CAPAs, complete Root Cause Analyses and risk assessments.
Write new SOPs and revise current SOPs as necessary.
Assist in proposal writing.
Qualifications/Skills
Required Knowledge/ Skills/Abilities
Lead development of project plan with minimal management review. Lead group collaborations and has advanced process and manufacturing knowledge.
Ability to troubleshoot and resolve advanced manufacturing issues and quality events.
Thorough understanding of cGMP and GDP requirements for drug substance manufacturing.
Strong knowledge of manufacturing equipment operations including batch reactors, filters, dryers, pumps and glass lab equipment. Able to train others on set up and operation of any Manufacturing equipment.
Identify and communicate schedule changes for suite operations, cleaning verifications and materials management.
Effectively communicates both verbally and in writing with internal and external team members.
Capable of managing 2 or more projects in parallel when needed.
Skills in Synthetic/Organic Chemistry and Math
Read and understand routine analytical data such as HPLC, GC, ROI, KF, and NMR data.
Identifies chemical hazards from SDS and process risks from safety evaluation and trains others on safe operating procedures.
Ability to wear respirators and various @types of PPE while promoting a safe work environment. Holds peers and junior staff accountable for proper PPE use.
Safely works with and supports manufacturing planning and execution of potent, highly toxic and flammable substances including training, waste handling, PPE identification.
Education, Experience & Licensing Requirements
Education & Experience
HS diploma with 17+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
BS in Chemistry or related field with 13+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
MS in Chemistry or related field and 11+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
PhD in Chemistry or related field and 6+ years of relevant pharmaceutical drug substance API manufacturing experience
Supervision Received: General Supervision
Exercises independent judgment for obtaining results. May determine the methods and procedures on new assignments in alignment with senior department management expectations but still accomplishes goals within defined procedures and practices. Seeks management direction to ensure alignment and for problems of diverse and/or complex scope.
Travel: 0-5%
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 30 pounds and occasionally lift and/or move up to 50+ pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. The employee will often be required to wear various respirators and often use full face respirators with supplied air and must be physically fit to do so as required.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and will work with a variety chemicals and solvents. The noise level in the work environment is usually under 60 db but can occasionally exceed that. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various @types of respirators/breathing apparatus, lab coats, gloves, ear protection, etc.
LIMITATIONS AND DISCLAIMER
The hiring range in Colorado for this position is $90,000 - $120,000; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity, and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
